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Haut-Tief Patient Education on Psoriasis and Eczema

Primary Purpose

Psoriasis, Atopic Dermatitis/ Eczema

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Control
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psoriasis focused on measuring psoriasis, atopic dermatitis, eczema, patient education, stress reduction, quality of life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic psoriasis (disease for more than 3 months)
  • Chronic eczema (disease for more than 3) months)
  • Age ≥ 18 years
  • Oral and written informed consent

Exclusion Criteria:

  • systemic antiinflammatory therapy
  • treatment with other investigational products
  • other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc),
  • known or suspected non-compliance, drug or alcohol abuse,
  • inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject
  • participation in another study within the 30 days preceding and during the present study, (viii) previous enrollment into the current study,
  • enrolment of the investigator, his/her family members, employees and other dependent persons.

Sites / Locations

  • University Hospital Zurich, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Haut Tief patient education

Arm Description

patient group receiving regular follow-up visits (baseline, 3 months, 6 months, 9 months)

patient group receives the educational program with regular follow-up visits (baseline, 3 months, 6 months, 9 months).

Outcomes

Primary Outcome Measures

change in DLQI (Dermatology Life Quality Index) score [ ]
DLQI is a questionnaire measuring Health related quality of life 10 questions
change in Skindex-29 score [ ]
Questionnaire measuring Health related quality of life 29 questions
change in ShortForm 36 score [ ]
Questionnaire measuring Health related quality of life
change in EQ 5D score [ ]
Questionnaire measuring Health related quality of life
change in EQ VAS (EQ visual analogue scale) score [ ]
Questionnaire measuring Health related quality of life

Secondary Outcome Measures

change in EASI (eczema area and severity index) score [ ]
clinical score for atopic dermatitis
change in PASI (psoriasis area and severity index) [ ]
clinical score for psoriasis
BDI (Beck Depression Inventory) score [ ]

Full Information

First Posted
July 14, 2014
Last Updated
July 25, 2019
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02205593
Brief Title
Haut-Tief Patient Education on Psoriasis and Eczema
Official Title
A Prospective, Randomized, Controlled Study of the Impact of Education and Stress-reduction Techniques on Psoriasis and Eczema.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
'Haut-Tief' (Skin Deep) is an educational, stress reducing program for patients with psoriasis or atopic dermatitis. A range of support activities will be offered in order to learn effective self-management strategies and attitude to one's chronic skin disease and consequently improving quality of life.
Detailed Description
The educational program consists of 2-hours of educational (dermatology, specialized nurse, psychologist) and stress-reduction sessions (yoga, meditation, physiotherapy) twice a week during 9 weeks. A multidisciplinary team of trainers is involved. Primary endpoint is the general and skin dependent quality of life measured by questionnaires. HRQoL (Health-Related Quality of Life) is measured at baseline, after 3 months, 6 months and 9 months follow up. Patients are recruited from the out-patient clinic at the Department of Dermatology of the University Hospital Zurich. Patients are randomized in an intervention and control group. Intervention group receives the education program additionally to follow-up visits whereas the control group receives follow-up visits. Several runs are planned.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Atopic Dermatitis/ Eczema
Keywords
psoriasis, atopic dermatitis, eczema, patient education, stress reduction, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
patient group receiving regular follow-up visits (baseline, 3 months, 6 months, 9 months)
Arm Title
Haut Tief patient education
Arm Type
Active Comparator
Arm Description
patient group receives the educational program with regular follow-up visits (baseline, 3 months, 6 months, 9 months).
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Regular follow-up and treatment WITHOUT behavioural intervention
Primary Outcome Measure Information:
Title
change in DLQI (Dermatology Life Quality Index) score [ ]
Description
DLQI is a questionnaire measuring Health related quality of life 10 questions
Time Frame
baseline, 3 months, 6 months, 9 months
Title
change in Skindex-29 score [ ]
Description
Questionnaire measuring Health related quality of life 29 questions
Time Frame
baseline, 3 months, 6 months, 9 months
Title
change in ShortForm 36 score [ ]
Description
Questionnaire measuring Health related quality of life
Time Frame
baseline, 3 months, 6 months, 9 months
Title
change in EQ 5D score [ ]
Description
Questionnaire measuring Health related quality of life
Time Frame
baseline, 3 months, 6 months, 9 months
Title
change in EQ VAS (EQ visual analogue scale) score [ ]
Description
Questionnaire measuring Health related quality of life
Time Frame
baseline, 3 months, 6 months, 9 months
Secondary Outcome Measure Information:
Title
change in EASI (eczema area and severity index) score [ ]
Description
clinical score for atopic dermatitis
Time Frame
baseline, 3 months, 6 months, 9 months
Title
change in PASI (psoriasis area and severity index) [ ]
Description
clinical score for psoriasis
Time Frame
baseline, 3 months, 6 months, 9 months
Title
BDI (Beck Depression Inventory) score [ ]
Time Frame
baseline, 3 months, 6 months, 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic psoriasis (disease for more than 3 months) Chronic eczema (disease for more than 3) months) Age ≥ 18 years Oral and written informed consent Exclusion Criteria: systemic antiinflammatory therapy treatment with other investigational products other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc), known or suspected non-compliance, drug or alcohol abuse, inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject participation in another study within the 30 days preceding and during the present study, (viii) previous enrollment into the current study, enrolment of the investigator, his/her family members, employees and other dependent persons.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guenther Hofbauer, Prof MD
Organizational Affiliation
University Hospital Zurich, Dept. of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Department of Dermatology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Haut-Tief Patient Education on Psoriasis and Eczema

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